Drug Pipeline MONTHLY UPDATE Critical updates in an ever changing environment December 2020 NEW DRUG INFORMATION ™ ● Xofluza (baloxavir marboxil) oral suspension: The U.S. Food and Drug Administration (FDA) approved Roche’s Xofluza for post-exposure prophylaxis of influenza in persons 12 years of age and older, following contact with an individual who has influenza. Additionally, Xofluza is indicated for treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. Xofluza’s new formulation is a 2mg/mL oral suspension that is administered as a one-time dose and will be available for children ages 1 to less than 12 years of age or those who have difficulty swallowing. Xofluza is already approved as a 20 and 40mg tablet. Xofluza’s approval was based on a placebo-controlled study that evaluated the prevention of influenza. Xofluza demonstrated a statistically significant 13% reduction in influenza transmission compared to placebo.1 Xofluza oral suspension launch and pricing are pending. ™ ● Thyquidity (levothyroxine sodium) oral solution: The FDA has approved Reguliance’s Thyquidity as replacement therapy in primary, secondary, and tertiary congenital or acquired hypothyroidism as well as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Thyquidity was approved via the 505(b)2 pathway based on the safety and efficacy of Synthroid.2 Thyquidity launch and pricing are pending. ™ ● Hetlioz LQ (tasimelteon): Vanda Pharmaceuticals’ Hetlioz LQ has been approved by the FDA for nighttime sleep disturbances associated with Smith-Magenis syndrome (SMS). SMS is a rare neurodevelopmental disorder where the patients have “inverted” circadian rhythm. It is available in two formulations: a liquid suspension for children and a capsule for adults. Approval is based on a single placebo-controlled efficacy study of Hetlioz LQ. Hetlioz LQ resulted in statistically significant improvement in the 50% worst nights’ sleep quality.3 Hetlioz capsules and Hetlioz LQ oral suspension are not substitutable. Hetlioz capsules for adults will be immediately available; Hetlioz LQ liquid formulation for children will be available in the first quarter of 2021 with pricing to follow. ® ● Klisyri (tirbanibulin): The FDA approved Athenex’s Klisyri for the topical treatment of actinic keratosis (AK) on the face or scalp. AK is a pre-cancerous skin lesion and the second most common diagnosis made by dermatologist in the United States. Left untreated, 10 – 15% of AK lesions will develop into skin cancers. Klisyri is a first-in-class microtubule inhibitor that is a 1% ointment (10mg/g) that is applied once daily for five days. Klisyri was approved based on two Phase 3 clinical trials that demonstrated complete clearance of actinic keratosis lesions at day 57 when compared to vehicle.4 Klisyri achieved a significantly higher number of patients with complete (100%) clearance of AK lesions in the treated area compared to vehicle (44% vs. 5% in study 1 and 54% vs. 13% in study 2). Athenex is expected to launch Klisyri by the first quarter of 2021 with pricing to follow. While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner. Drug Pipeline Monthly Update: December 2020 Page 2 GENERIC DRUG INFORMATION ® ● Ofirmev (acetaminophen inj, 10mg/mL): Auromedics Pharma launched their generic version of Mallinckrodt Hospital’s Ofirmex to reduce fever, or to treat mild to moderate pain. Ofirmev generated $379 million in U.S. annual sales in 2019. Multiple manufacturers are set to launch this year. ® ● Alinia (nitazoxanide) tablet: Rising Pharmaceuticals launched their generic version of Romark Pharmaceuticals’ Alinia as an antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Alinia generated $70 million in U.S. annual sales in 2019. ® ● Sklice (ivermectin lotion): Taro launched their generic version of Arbor Pharmaceuticals Sklice lotion as a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older. Sklice generated $35 million in U.S. annual sales in 2019. ® ● Entereg (alvimopan): Actavis Pharma launched their generic version of Merck Sharp & Dohme’s Entereg as a peripherally acting μ-opioid receptor antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. Entereg generated $107 million in U.S. annual sales in 2019. ® ● Saphris (asenapine maleate): Breckenridge launched their generic version of Allergan’s Saphris for the treatment of bipolar disorder and schizophrenia. Multiple manufacturers are set to launch before the end of the year. Saphris generated $255 million in U.S. annual sales in 2019. + Specialty medication Drug Pipeline Monthly Update: December 2020 Page 3 NEW MOLECULAR ENTITY APPROVALS IN THE PAST TWELVE MONTHS DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* tirbanibulin Klisyri® Athenex and Almirall Actinic keratosis December 2020 clascoterone Winlevi™ Cassiopea SPA Acne August 2020 fostemsavir Rukobia™ Viiv Healthcare HIV August 2020 oliceridine Olinvyk™ Trevena Pain August 2020 nifurtimox Lampit™ Bayer Pediatric Chagas disease August 2020 abametapir Xeglyze™ Hatchtech Head lice treatment July 2020 remimazolam Byfavo™ Acacia Pharma Procedure sedation July 2020 rimegepant Nurtec ODT™ Biohaven Acute migraine February 2020 eptinezumab-jjmr Vyepti™ Adler Migraine prevention February 2020 BioPharmaceuticals amisulpride Barhemsys® Acacia Pharma Post-operative nausea & vomiting February 2020 bempedoic acid Nexletol® Esperion High cholesterol February 2020 Therapeutics Inc *Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer. Drug Pipeline Monthly Update: December 2020 Page 4 OTHER NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* tasimelteon Hetlioz LQ™ Vanda Pharmaceuticals Sleep disorders December 2020 levothyroxine sodium Thyquidity™ Reguliance Hypothyroidism November 2020 baloxavir marboxil oral Xofluza™ Roche Influenza November 2020 suspension fosphenytoin sodium Sesquient™ Sedor Pharmaceuticals Status epilepticus November 2020 sodium sulfate, magnesium Sutab® Sebela Colonoscopy preparation November 2020 sulfate, and potassium chloride Pharmaceuticals tablets loteprednol etabonate 0.25% Eysuvis™ Kala Pharmaceuticals Dry eyes October 2020 bupivacaine hydrochloride Xaracoll™ Innocoll Holdings Postsurgical pain August 2020 collagen-matrix implants Limited calcipotriene 0.005% and Wynzora™ MC2 Therapeutics Plaque psoriasis July 2020 betamethasone 0.064% cream budesonide/glycolpyrronium/ Breztri™ Aerosphere AstraZeneca COPD July 2020 formoterol fumarate oxymetazoline ophthalmic Upneeq™ Vertical Acquired blepharoptosis (droopy eyelid) July 2020 solution 0.1% Pharmaceuticals (Osmotica) metoclopramide nasal spray Gimoti™ Evoke Pharma Diabetic gastroparesis June 2020 insulin lispro-aabc Lyumjev™ Lilly Diabetes mellitus June 2020 insulin glargine Semglee™ Mylan and Biocon Diabetes mellitus June 2020 dolutegravir Tivicay PD™ Viiv Healthcare HIV-1 June 2020 minocycline topical foam Zilxi™ Foamix Rosacea June 2020 Pharmaceuticals lactic acid, citric acid, and Phexxi™ Evofem Pregnancy prevention May 2020 potassium bitartrate celecoxib oral solution Elyxyb™ Promius Pharma Acute migraine May 2020 elagolix, estradiol and Oriahnn™ AbbVie/Neurocrine Menstrual bleeding associated with May 2020 norethindrone acetate Biosciences uterine leiomyomas progesterone Milprosa™ Ferring Female infertility April 2020 Pharmaceuticals opicapone Ongentys™ Neurocrine Biosciences Parkinson’s disease April 2020 ferric pyrophosphate citrate Triferic Avnu™ Rockwell Medical Maintain hemoglobin in hemodialysis- March 2020 dependent chronic kidney disease bimatoprost sustained-release Durysta™ Allergan Open-angle glaucoma or ocular February 2020 (SR) hypertension bempedoic acid/ezetimibe Nexlizet™ Esperion Therapeutics High cholesterol February 2020 semaglutide, oral tablet Rybelsus™ Novo Nordisk Diabetes February 2020 continued Drug Pipeline Monthly Update: December 2020 Page 5 OTHER NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS (continued) DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) APPROVED* ethinyl estradiol and Twirla™ Agile Therapeutics Pregnancy prevention February 2020 levonorgestrel transdermal system meloxicam IV Anjeso™ Baudax Bio Pain February 2020 lactitol Pizensy™ Braintree Laboratories Chronic idiopathic constipation February 2020 Inc. empagliflozin, linagliptin and Trijardy XR™ Boehringer Ingelheim Type 2 diabetes January 2020 metformin XR and Eli Lilly fidaxomicin Dificid™ Merck Clostridium difficile-associated diarrhea January 2020 (CDAD) ferric derisomaltose Monoferric™ Pharmacosmos IV iron replacement product January 2020 tazarotene Arazlo™ Ortho Dermatologics Acne vulgaris January 2020 diazepam Valtoco™ Neurelis Seizures